Regulatory, Medical Writing Manager
Location - UK, Italy, Spain, Netherlands, Poland, France, and Germany
(Fully Remote)
Medical Writing Manager opportunity working for a leading global clinical research organisation that works with a number of top 5 pharmaceutical companies, and growing biotechs.
As a Lead Medical Writer, you will manage and support all Regulatory and Clinical writing for a number of exciting projects. You will be responsible for the preparation of clinical regulatory documentation for regulatory submissions, writing clinical documents e.g. IBs, CSRs, clinical overviews, module 2 clinical summaries, paediatric plans, orphan designation applications, and regulatory briefing documents.
The role will be supporting junior medical writers by reviewing the documentation including offering training and support. As a Medical Writing Manager, you will sit within a large and interactive team of other regulatory writers and support a number of innovative projects.
Responsibilities
• Initial Investigational New Drug (IND) applications and amendments
• Clinical study protocols and protocol amendments
• Investigator's brochures and updates
• Interim and final clinical study reports
• IND annual reports
• Development safety update reports
Requirements
• Multiple years working in a medical writing position. 5+ years prior experience in a CRO/pharmaceutical environment
• Supported junior team members, with reviewing documents and provided training and mentoring
• Experience working as the lead writer on multiple regulatory and clinical documentation
• Bachelor’s degree required / Advanced degree preferred
This is an excellent opportunity to gain further exposure in Medical Writing, acting as a senior figure within a leading business. This role can be a fully remote position across Europe and comes with an attractive package and a number of career development opportunities.
If you are interested in this role or would like more details please email your CV to [email protected]
Remember if this role is not suitable for you please feel free to forward this to anyone you feel would be suitable. If we successfully find a role for your recommendation we will give you £250 in vouchers of your choice.